SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors

NCT06634706 | Not Yet Recruiting DMC

• 1 other identifier: 985-00007
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed or orphan. The study is designed to gather essential imaging data on the RefleXion Medical Radiotherapy System (RMRS) to validate the accuracy of FDG-directed BgRT, also known as SCINTIX therapy, in various anatomical groupings. Study subjects will go through the entire SCINTIX treatment workflow, including radiopharmaceutical administration and live PET imaging, but without turning on the treatment beam. Collected data will be used offline to generate the set of machine instructions that would have been used during treatment delivery to calculate the "emulated" BgRT dose distribution, i.e., what the delivered dose would have been had the treatment beam been turned on during the session. The 6th category ("Distributed or orphan") is meant to capture tumor types that can manifest across anatomies and/or for which utilization of stereotactic radiotherapy for treatment is relatively rare, with lymphomas being a prototypical example.

Conditions

Thoracic Cancer; Head and Neck Cancer; Pelvic Cancer; Hepatobiliary Carcinoma in Situ; Retroperitoneal Cancer; Distributed and Orphan Tumors

Outcome Measures

Primary Outcomes (1)

• Emulated BgRT Delivery accuracy

  The percent of radiotherapy fractions where the emulated BgRT dose distribution is shown to be consistent with the approved BgRT treatment plan (i.e., 95% of DVHDelivered points for the BTZ and OAR fall within bounded DVH of the approved BgRT plan).

  Assessed for each emulated delivery through study completion, an average of 2 years

Secondary Outcomes (1)

• BgRT deliverability

  Assessed for each emulated delivery through study completion,an average of 2 years

Study Arms (6)

Cohort 1 - Head and Neck Tumors

OTHER

Tumors in the following regions: Larynx, Salivary glands, Thyroid gland, Head and Neck lymph nodes, Oral cavity, Oropharynx, Nasopharynx, and Hypopharynx

Device: RefleXion X1 Radiotherapy System [Imaging Only]

Cohort 2 - Thoracic Tumors

OTHER

Tumors in the following regions: Thoracic lymph nodes, Thymus, Esophagus, and Breast,

Device: RefleXion X1 Radiotherapy System [Imaging Only]

Cohort 3 - Hepatobiliary Tumors

OTHER

Tumors in the following regions: Liver and intrahepatic ducts, Gallbladder, Extrahepatic bile ducts, and Hepatic lymph nodes,

Device: RefleXion X1 Radiotherapy System [Imaging Only]

Cohort 4 - Retroperitoneal Tumors & non-Hepatobiliary Abdominal Tumors

OTHER

Tumors in the following regions: Kidneys, Adrenal gland, Pancreas, Retroperitoneal lymph nodes, Stomach, Spleen, Small intestine, and Colon

Device: RefleXion X1 Radiotherapy System [Imaging Only]

Cohort 5 - Pelvic Tumors

OTHER

Tumors in the following regions: Prostate, Bladder, Ureter, Urethra, Cervix, Ovaries, Fallopian tubes, Vagina, Colon \[Sigmoid\], Rectum, Anus, and Pelvic lymph nodes.

Device: RefleXion X1 Radiotherapy System [Imaging Only]

Cohort 6 - Other and Orphan Tumors

OTHER

Tumors in the following regions: \* Locations not listed in Cohorts 1-5, however; considered at physicians discretion i.e. Lymphoma \[Head and Neck\], Thorax, Abdomen, and Pelvis

Device: RefleXion X1 Radiotherapy System [Imaging Only]

Interventions

RefleXion X1 Radiotherapy System [Imaging Only] DEVICE

kVCT and FDG-PET imaging using the RefleXion X1 Radiotherapy System in different anatomical regions

Also known as: RefleXion Medical Radiotherapy System

Cohort 1 - Head and Neck Tumors; Cohort 2 - Thoracic Tumors; Cohort 3 - Hepatobiliary Tumors; Cohort 4 - Retroperitoneal Tumors & non-Hepatobiliary Abdominal Tumors; Cohort 5 - Pelvic Tumors; Cohort 6 - Other and Orphan Tumors

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 21 years.
• A new or prior diagnosis of biopsy-proven cancer.
• At least one active non-osseous primary or metastatic tumor that is located in one of the assigned anatomical groupings and dispositioned to undergo 3-5 fractions of SBRT. A lesion is considered active if viable malignancy is confirmed either by biopsy or by diagnostic imaging (as interpreted by the multidisciplinary care team).
• Target tumor size ≥2cm and ≤5cm.
• Target tumor is discrete and assessed by investigator to meet diagnostic PET screening criteria for BgRT candidacy:
• SUVmax≥6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
• Ratio of target tumor SUVmax to SUVmean of local background region (defined as a 3 mm shell 1.5 cm from the target tumor) is greater than 6, as assessed on diagnostic PET/CT performed within 60 days of enrollment with no new intervening oncologic therapies.
• ECOG Performance Status 0-3.
• Must have completed any other oncologic therapies at least 15 days prior to planned start of study procedures (preferably 30 days) and must have no plans to initiate systemic therapy until after study follow up is complete -OR- must be recorded by physician to have an active lesion that is unresponsive to ongoing systemic therapy.
• Females of childbearing potential should have a negative urine or serum pregnancy test within 14 days prior to initiation of study scans.

You may not qualify if:

• Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan.
• Lung parenchymal and bone target tumors
• At the physician's discretion regarding expected target motion, FDG-avid structures not intended for radiation are within:
• cm from target on diagnostic PET/CT in directions where limited target motion is expected
• cm from target on diagnostic PET/CT in directions where sizable target motion is expected
• Known allergy to FDG.
• Known psychiatric or substance abuse disorder that would interfere with conduct of the study.
• Pregnant, breast-feeding or expecting to conceive during the study.
• Patient weight exceeding the weight limit outlined per user manual.
• Patients with pacemakers and other implantable devices deemed at high risk by the treating physician for complications secondary to radiotherapy, according to institutional guidelines and published guidelines (e.g. AAPM task group-203).
• Active inflammatory bowel disease, scleroderma, or other disorder deemed by the treating physician to put the patient at risk for excess toxicity in the setting of external beam radiation therapy (EBRT) or FDG injection.

Sponsors & Collaborators

• RefleXion Medical: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sean S. Shirvani, MD

  RefleXion Medical Inc

  STUDY DIRECTOR

Central Study Contacts

Debradenise S. Brooks

CONTACT

6504828435; dbrooks@reflexion.com

Mario Esquivel

CONTACT

mesquivel@reflexion.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 10, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08